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Results: 1-10 of 11

The top 5 corruption risks for pharmaceutical and medical device companies

  • LeClairRyan
  • -
  • USA
  • -
  • September 19 2012

Pharmaceutical and medical device companies are fast becoming the enforcement punching bag, eclipsing the long-suffering status of the oil and gas energy

GlaxoSmithKline LLC to pay the largest health care fraud settlement in U.S. history

  • Bricker & Eckler LLP
  • -
  • USA
  • -
  • July 3 2012

The United States Department of Justice (DOJ) announced on July 2, 2012, that drug maker GlaxoSmithKline LLC (GSK) has agreed to plead guilty and pay $3 billion the largest penalty ever paid by a pharmaceutical company to resolve its criminal and civil liability for off-label promotion of several drugs, failure to report safety data, and false price reporting practices

Supreme Court grants cert to determine if plaintiff must prove materiality before certifying class in securities fraud class action

  • Porter Wright Morris & Arthur LLP
  • -
  • USA
  • -
  • June 12 2012

On Monday, June 11, 2012, the Supreme Court granted a Writ of Certiorari in Amgen, Inc. v. Connecticut Retirement Plans and Trust Funds, No. 11-1085 (U.S. Jun. 11, 2012) to decide whether, in a misrepresentation case under SEC Rule l0b-5, the court must require proof of materiality before certifying a plaintiff class based on the fraud-on-the-market theory (and whether the court must allow the defendants to present evidence rebutting the applicability of the fraud-on-the-market theory before certifying the class

Boston Scientific prevails in securities fraud lawsuit

  • Winston & Strawn LLP
  • -
  • USA
  • -
  • August 22 2011

On August 15th, the First Circuit addressed what adverse events associated with medical devices an issuer must disclose, affirming the entry of summary judgment dismissing a Rule 10b-5 securities fraud lawsuit

U.S. Supreme Court: disclosing “statistically significant” incidents regarding a product’s potential adverse health effects is not enough

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 29 2011

The Supreme Court recently issued a unanimous decision in a securities fraud case, Matrixx Initiatives, Inc. v. Siracusano

Matrixx Initiatives, Inc. v. Siracusano

  • Dorsey & Whitney LLP
  • -
  • USA
  • -
  • March 25 2011

Failure to disclose a statistically insignificant incidence of adverse side effects could lead to significant securities-fraud liability for publicly traded drugmakers, device manufacturers, and others under a recent Supreme Court decision

Matrixx Securities fraud case could affect product liability law

  • Squire Sanders
  • -
  • USA
  • -
  • December 10 2010

Sometimes the most significant changes in the law come from unexpected places

Indictment of former GlaxoSmithKline in-house attorney highlights risks and provides lessons for handling document requests in government investigations

  • Jenner & Block
  • -
  • USA
  • -
  • November 23 2010

A former in-house counsel at pharmaceutical company GlaxoSmithKline ("GSK"), Lauren Stevens, was indicted earlier this month for obstruction of a proceeding, false statements, and falsifying or concealing documents for her role in responding to a document request from the Food and Drug Administration ("FDA"

New indictment of in-house counsel indicates enhanced efforts to hold corporate executives accountable for food and drug law violations

  • Fish & Richardson PC
  • -
  • USA
  • -
  • November 15 2010

This year, both the Food and Drug Administration (FDA) and Department of Justice have repeatedly signaled to the pharmaceutical and medical device industries that they should expect an increase in the criminal prosecution of individuals for alleged violations of the food and drug laws, with the stated goals of increasing deterrence and greater compliance

FDA to increase enforcement actions against corporate officials

  • Faegre Baker Daniels
  • -
  • USA
  • -
  • March 5 2010

Corporate executives have rarely been personal targets of FDA enforcement actions

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